MACH 4 Universal HRP-Polymer Detection System
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- MACH 4 Universal HRP-Polymer Detection System EUDAMEDFDA UDIMACH 4 Universal HRP-Polymer EUDAMEDFDA UDI
- Generic Name
- Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry FDA UDIPolymer-enzyme conjugate IVD, reagent FDA UDI
- Device Name
- MACH Mirco-Polymer Detection System for IHC EUDAMED
- Model / Reference
- BRI4012L EUDAMEDFDA UDIM4U534G EUDAMEDFDA UDIM4U534H EUDAMEDFDA UDIMACH Mirco-Polymer Detection System for IHC EUDAMEDBRl4012G EUDAMEDBRI4012G FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847627005212 EUDAMEDFDA UDI00847627009234 EUDAMEDFDA UDI00847627005199 EUDAMEDFDA UDI00847627009258 EUDAMEDFDA UDI
- Basic UDI-DI
- 08476270BMACH421JC EUDAMED
- FDA Product Code
- PPM FDA UDINJT FDA UDI
- EMDN Code
- W01029099 IMMUNOCHEMISTRY REAGENTS - OTHER EUDAMED
- GMDN Term
- Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry FDA UDIPolymer-enzyme conjugate IVD, reagent FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.4010 FDA UDI864.1860 FDA UDI
- Market of Registration
- Germany EUDAMEDSweden EUDAMEDHungary EUDAMEDDenmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
MACH 4 Universal HRP-Polymer Detection System by Biocare Medical, Llc — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biocare Medical, Llc
Sources (8)
- FDA UDI 3d16022c-efa5-4052-b26e-ba1d0555ea9b 33 fields · synced Jul 28, 2026
- FDA UDI 8ddb03c5-701e-402b-b163-02f2dd0c519a 33 fields · synced May 29, 2026
- FDA UDI 366b0299-c42b-4432-99b9-1d1783d4a34b 33 fields · synced May 30, 2026
- FDA UDI e99df68a-6920-4879-bbfb-bf15c95fac51 33 fields · synced May 30, 2026
- EUDAMED 1dbcc1c4-cd9c-46a0-93af-d031f53d1e5d 61 fields · synced Jul 9, 2026
- EUDAMED 0505fcde-3510-4c4d-a545-63cc10367004 61 fields · synced Jul 11, 2026
- EUDAMED 049af5ad-8a00-42fc-9dbf-8d340f64c6ed 61 fields · synced Jul 16, 2026
- EUDAMED b399754d-b724-459d-bf3f-3dc236dbc6b1 61 fields · synced Jul 28, 2026